A Phase 1/2 interventional study of 2-deoxy-2-[18F]fluoro-D-glucose (FDG) and 3'-deoxy-3'-[18F]fluorothymidine (FLT) in Non-Small Cell Lung Cancer, sponsored by Genentech, Inc.. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-03-31.
Sponsored by Genentech, Inc. · Phase 1/2, Interventional, and Treatment
This is a single-arm, open-label, multicenter, international pilot study to evaluate changes that occur in 2-deoxy-2-[18F]fluoro-D-glucose (FDG)- and 3'-deoxy-3'-[18F]fluorothymidine(FLT)-PET (Positron Emission Tomography) imaging as a result of treatment with erlotinib in patients with recurrent or refractory non-small cell lung cancer (NSCLC). The study will enroll approximately 30 patients at approximately 4 sites in Australia and 2 sites in the United States.
7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.
This study's enrollment of 88 is above the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.
Browse Lung Neoplasms studies →Genentech, Inc. is the lead sponsor of 507 studies on the registry; 23 are open to participants now.
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Exclusion Criteria:
Erlotinib 150 mg/day taken orally at approximately the same time of day with 200 mL (6-8 Ounces) of water on an empty stomach. Participants received Erlotinib for 1 year or until they developed progressive disease or intolerable toxicity. After 14 days and after 56 days of treatment with Erlotinib participants underwent FDG-PET and FLT-PET scans.
Other: 2-deoxy-2-[18F]fluoro-D-glucose (FDG) · Other: 3'-deoxy-3'-[18F]fluorothymidine (FLT) · Drug: erlotinib HCl
FDG prepared in sterile buffered solution for intravenous injection. Dosage was based on the participant's weight not to exceed 15 mCi (millicurie).
FLT 7 mCi dose prepared in sterile buffered solution for intravenous injection.
Tablets taken orally 150 mg/day.
Also known as: Tarceva
Progression Free Survival (PFS) of Groups by FDG Response at Day 56
PFS was defined as the time from the date of first erlotinib dose to disease progression or death, whichever occurs first. PFS was compared between patients with FDG-PET response and patients without FDG-PET response, independent of CT response (per RECIST 1.0) at Day 56 of treatment with erlotinib. Mean of the percent changes in maximal standard uptake values (mSUVmax) from FDG-PET scans was used to define FDG-PET response. Based on European Organization for Research on the Treatment of Cancer (EORTC) definitions, an objective FDG-PET response was defined an mSUVmax \<-25%.
Time frame: Time from first erlotinib treatment to disease progression on CT (per RECIST 1.0) or death, whichever occurs first, assessed up to 2 years
PFS of Patients With FDG-PET Complete Response (CR)/Partial Response (PR) Versus FDG-PET Progressive Disease (PD) in Patients With Computed Tomography (CT) Stable Disease (SD) at Day 56
PFS was defined as the time from the date of first erlotinib dose to disease progression or death, whichever occurs first. PFS was compared between patients with FDG-PET response (Complete /Partial Responses) and patients with FDG-PET progression, within the subset of patients who demonstrated stable disease on CT (per RECIST 1.0) at Day 56 of treatment with erlotinib. FDG-PET response; defined as a mSUVmax from FDG-PET scans of \<-25% and FDG-PET disease progression; defined as a mSUVmax \>+25% or the development of a new lesion with a mSUVmax above background not explained by another cause.
Time frame: Time from first erlotinib treatment to disease progression on CT (per RECIST 1.0) or death, whichever occurs first, assessed up to 2 years
Progression Free Survival of Groups by FLT Response at Day 56
PFS was defined as the time from the date of first erlotinib dose to disease progression or death, whichever occurs first. PFS was compared between patients with FLT-PET response and patients without FLT-PET response, independent of CT response (per RECIST 1.0) at Day 56 of treatment with erlotinib. FLT-PET response was defined as a mSUVmax from FLT-PET scans \<-25%.
Time frame: Time from first erlotinib treatment to disease progression on CT (per RECIST 1.0) or death, whichever occurs first, assessed up to 2 years
Progression Free Survival of Patients With FLT CR/PR Versus FLT PD in Patients With CT SD at Day 56
PFS was defined as the time from the date of first erlotinib dose to disease progression or death, whichever occurs first. PFS was compared between patients with FLT-PET response and patients without FLT-PET response, independent of computed tomography (CT) response (per RECIST 1.0) at Day 56 of treatment with erlotinib. FLT-PET response was defined as a mSUVmax from FLT-PET scans \<-25% and FLT-PET disease progression was defined as a mSUVmax from FLT-PET scans \>+25% or the development of a new lesion with a mSUVmax above background not explained by another cause.
Time frame: Time from first erlotinib treatment to disease progression on CT (per RECIST 1.0) or death, whichever occurs first, assessed up to 2 years
Overall Survival of Groups by FDG Response at Day 56
Overall survival (OS) was defined as the time from the date of first erlotinib dose to death. Overall survival (OS) was compared between patients with FDG-PET response and patients without FDG-PET response, independent of Response Evaluation Criteria in Solid Tumors (RECIST 1.0) computed tomography (CT) response at Day 56 of treatment with erlotinib. FDG-PET response was defined as a mSUVmax from FDG-PET scans \<-25%.
Time frame: From first erlotinib treatment to death, assessed up to 2 years
Overall Survival of Patients With FDG CR/PR Versus FDG PD in Patients With CT SD at Day 56
Overall survival (OS) was defined as the time from the date of first erlotinib dose to death. OS was compared between patients with FDG-PET response and patients with FDG-PET progression, within the subset of patients who demonstrated stable disease (SD) on CT (per RECIST 1.0) at Day 56 of treatment with erlotinib. FDG-PET response was defined as a mSUVmax from FDG-PET scans \<-25% and FDG-PET disease progression was defined as a mSUVmax from FDG-PET scans \>+25% or the development of a new lesion with a mSUVmax above background not explained by another cause.
Time frame: From first erlotinib treatment to death, assessed up to 2 years
Overall Survival of Groups by FLT Response at Day 56
Overall survival (OS) was defined as the time from the date of first erlotinib dose to death. OS was compared between patients with FLT-PET response and patients without FLT-PET response, independent of CT response (per RECIST 1.0) at Day 56 of treatment with erlotinib. FLT-PET response was defined as a mSUVmax from FLT-PET scans \<-25%.
Time frame: From first erlotinib treatment to death, assessed up to 2 years
Overall Survival of Patients With FLT CR/PR Versus FLT PD in Patients With CT SD at Day 56
Overall survival (OS) was defined as the time from the date of first erlotinib dose to death. OS was compared between patients with FLT-PET response and patients with FLT-PET progression, within the subset of patients who demonstrated SD on CT (per RECIST 1.0) at Day 56 of treatment with erlotinib. FLT-PET response was defined as a mSUVmax from FLT-PET scans of \<-25% and FLT-PET disease progression was defined as a mSUVmax from FLT-PET scans \>+25% or the development of a new lesion with a mSUVmax above background not explained by another cause.
Time frame: From first erlotinib treatment to death, assessed up to 2 years
Percentage of Patients With FDG-PET Responses
In patients with computed tomography (CT)-stable disease (according to RECIST 1.0) at 56 days of erlotinib treatment, the percentage of patients who demonstrated FDG-PET responses after the initial 14 days and 56 days of erlotinib treatment. FDG-PET response was defined as a mSUVmax from FDG-PET scans \<-25%. CT SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum longest diameter since the treatment started.
Time frame: Day 14 and Day 56
Percentage of Patients With FLT-PET Responses
In patients with CT-stable disease (according to RECIST 1.0) at 56 days of erlotinib treatment, the percentage of patients who demonstrated FLT-PET responses after the initial 14 days and 56 days of erlotinib treatment. FLT-PET response was defined as a mSUVmax from FLT-PET scans \<-25%. CT SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum longest diameter since the treatment started.
Time frame: Day 14 and Day 56
FDG Response in Subgroups by CT Response at Day 56
In patients with partial response or progressive disease on CT (per RECIST 1.0) after 56 days of erlotinib treatment, the percentage of patients who demonstrated FDG-PET responses on Day 56 defined as a mSUVmax from FDG-PET scans \<-25%. CT Partial Response defined as a 30% decrease in the sum of the longest diameter (LD) of target lesion taking as reference the baseline sum of the LD. CT Progressive disease defined as a 20% increase in the sum of the longest diameter of target lesions taking as reference the smallest sum LD since treatment started or appearance of 1 or more new lesions.
Time frame: Day 56
FLT Response in Subgroups by CT Response at Day 56
In patients with partial response or progressive disease on CT (per RECIST 1.0) after 56 days of erlotinib treatment, the percentage of patients who demonstrated FLT-PET responses on Day 56 defined as a mSUVmax from FLT-PET scans \<-25%. CT Partial Response defined as a 30% decrease in the sum of the longest diameter (LD) of target lesion taking as reference the baseline sum of the LD. CT Progressive disease defined as a 20% increase in the sum of the longest diameter of target lesions taking as reference the smallest sum LD since treatment started or appearance of 1 or more new lesions.
Time frame: Day 56
Number of Participants With Adverse Events Due to FLT-PET Imaging
The number of participants who experienced an adverse event judged by the investigator to be related to FLT-PET.
Time frame: From screening to Day 112 assessment visit or study discontinuation or termination, whichever is first. On visits after Day 112, only SAE were recorded.
A single-arm, open-label, multicenter, international pilot study. The study was expected to enroll approximately 100 evaluable patients at approximately eight sites in Australia and the United States. The study was initiated on 6 DEC 2006 and completed on 23 APR 2010.
| Milestone | Erlotinib |
|---|---|
| Started | 88 |
| Treated with erlotinib | 74 |
| Fdg-pet evaluable | 51 |
| Flt-pet evaluable | 50 |
| Completed | 1 |
| Not completed | 87 |
| Withdrew: Adverse event | 5 |
| Withdrew: Death | 7 |
| Withdrew: Physician decision | 2 |
| Withdrew: Withdrawal by subject | 3 |
| Withdrew: Progression of disease | 56 |
| Withdrew: Screening failure | 14 |
PFS was defined as the time from the date of first erlotinib dose to disease progression or death, whichever occurs first. PFS was compared between patients with FDG-PET response and patients without FDG-PET response, independent of CT response (per RECIST 1.0) at Day 56 of treatment with erlotinib. Mean of the percent changes in maximal standard uptake values (mSUVmax) from FDG-PET scans was used to define FDG-PET response. Based on European Organization for Research on the Treatment of Cancer (EORTC) definitions, an objective FDG-PET response was defined an mSUVmax \<-25%.
| weeks | Erlotinib_FDG Responders | Erlotinib_ FDG Non-Responders |
|---|---|---|
| Progression Free Survival (PFS) of Groups by FDG Response at Day 56 | 28.1 (16.14 to 40.14) | 12.1 (7.86 to 51.14) |
In patients with computed tomography (CT)-stable disease (according to RECIST 1.0) at 56 days of erlotinib treatment, the percentage of patients who demonstrated FDG-PET responses after the initial 14 days and 56 days of erlotinib treatment. FDG-PET response was defined as a mSUVmax from FDG-PET scans \<-25%. CT SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum longest diameter since the treatment started.
| Percentage of Participants | Erlotinib |
|---|---|
| Day 14 response | 7.7 (1.4 to 23.4) |
| Day 56 response | 11.5 (3.2 to 29.9) |
PFS was defined as the time from the date of first erlotinib dose to disease progression or death, whichever occurs first. PFS was compared between patients with FDG-PET response (Complete /Partial Responses) and patients with FDG-PET progression, within the subset of patients who demonstrated stable disease on CT (per RECIST 1.0) at Day 56 of treatment with erlotinib. FDG-PET response; defined as a mSUVmax from FDG-PET scans of \<-25% and FDG-PET disease progression; defined as a mSUVmax \>+25% or the development of a new lesion with a mSUVmax above background not explained by another cause.
| weeks | Erlotinib_FDG Responders With CT SD at Day 56 | Erlotinib_FDG Progressive Disease With CT SD at Day 56 |
|---|---|---|
| PFS of Patients With FDG-PET Complete Response (CR)/Partial Response (PR) Versus FDG-PET Progressive Disease (PD) in Patients With Computed Tomography (CT) Stable Disease (SD) at Day 56 | 32.1 (18 to 32.14) | 14.9 (8.14 to 32.14) |
In patients with CT-stable disease (according to RECIST 1.0) at 56 days of erlotinib treatment, the percentage of patients who demonstrated FLT-PET responses after the initial 14 days and 56 days of erlotinib treatment. FLT-PET response was defined as a mSUVmax from FLT-PET scans \<-25%. CT SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum longest diameter since the treatment started.
| Percentage of Participants | Erlotinib |
|---|---|
| Day 14 response | 7.7 (1.4 to 23.4) |
| Day 56 response | 7.7 (1.4 to 23.4) |
PFS was defined as the time from the date of first erlotinib dose to disease progression or death, whichever occurs first. PFS was compared between patients with FLT-PET response and patients without FLT-PET response, independent of CT response (per RECIST 1.0) at Day 56 of treatment with erlotinib. FLT-PET response was defined as a mSUVmax from FLT-PET scans \<-25%.
| weeks | Erlotinib_FLT Responders | Erlotinib_ FLT Non-Responders |
|---|---|---|
| Progression Free Survival of Groups by FLT Response at Day 56 | 39.9 (18 to 40.14) | 13.1 (7.86 to 51.14) |
PFS was defined as the time from the date of first erlotinib dose to disease progression or death, whichever occurs first. PFS was compared between patients with FLT-PET response and patients without FLT-PET response, independent of computed tomography (CT) response (per RECIST 1.0) at Day 56 of treatment with erlotinib. FLT-PET response was defined as a mSUVmax from FLT-PET scans \<-25% and FLT-PET disease progression was defined as a mSUVmax from FLT-PET scans \>+25% or the development of a new lesion with a mSUVmax above background not explained by another cause.
| weeks | Erlotinib_FLT Responders With CT SD at Day 56 | Erlotinib_FLT Progressive Disease With CT SD at Day 56 |
|---|---|---|
| Progression Free Survival of Patients With FLT CR/PR Versus FLT PD in Patients With CT SD at Day 56 | NA (18 to 24) | 12.9 (8.29 to 17.29) |
Overall survival (OS) was defined as the time from the date of first erlotinib dose to death. Overall survival (OS) was compared between patients with FDG-PET response and patients without FDG-PET response, independent of Response Evaluation Criteria in Solid Tumors (RECIST 1.0) computed tomography (CT) response at Day 56 of treatment with erlotinib. FDG-PET response was defined as a mSUVmax from FDG-PET scans \<-25%.
| months | Erlotinib_FDG Responders | Erlotinib_ FDG Non-Responder |
|---|---|---|
| Overall Survival of Groups by FDG Response at Day 56 | NA (4.99 to 23.98) | 7.8 (1.94 to 24.51) |
In patients with partial response or progressive disease on CT (per RECIST 1.0) after 56 days of erlotinib treatment, the percentage of patients who demonstrated FDG-PET responses on Day 56 defined as a mSUVmax from FDG-PET scans \<-25%. CT Partial Response defined as a 30% decrease in the sum of the longest diameter (LD) of target lesion taking as reference the baseline sum of the LD. CT Progressive disease defined as a 20% increase in the sum of the longest diameter of target lesions taking as reference the smallest sum LD since treatment started or appearance of 1 or more new lesions.
| Percentage of participants | Erlotinib |
|---|---|
| CT Partial response (n=4) | 75 (24.9 to 98.7) |
| CT Progressive Disease (n=21) | 0 (0 to 14.6) |
In patients with partial response or progressive disease on CT (per RECIST 1.0) after 56 days of erlotinib treatment, the percentage of patients who demonstrated FLT-PET responses on Day 56 defined as a mSUVmax from FLT-PET scans \<-25%. CT Partial Response defined as a 30% decrease in the sum of the longest diameter (LD) of target lesion taking as reference the baseline sum of the LD. CT Progressive disease defined as a 20% increase in the sum of the longest diameter of target lesions taking as reference the smallest sum LD since treatment started or appearance of 1 or more new lesions.
| Percentage of participants | Erlotinib |
|---|---|
| CT Partial response (n=4) | 50 (9.8 to 90.2) |
| CT Progressive Disease (n=20) | 0 (0 to 15.4) |
Overall survival (OS) was defined as the time from the date of first erlotinib dose to death. OS was compared between patients with FDG-PET response and patients with FDG-PET progression, within the subset of patients who demonstrated stable disease (SD) on CT (per RECIST 1.0) at Day 56 of treatment with erlotinib. FDG-PET response was defined as a mSUVmax from FDG-PET scans \<-25% and FDG-PET disease progression was defined as a mSUVmax from FDG-PET scans \>+25% or the development of a new lesion with a mSUVmax above background not explained by another cause.
| months | Erlotinib_FDG Responders With CT SD at Day 56 | Erlotinib_FDG Progressive Disease With CT SD at Day 56 |
|---|---|---|
| Overall Survival of Patients With FDG CR/PR Versus FDG PD in Patients With CT SD at Day 56 | 12.2 (4.99 to 17.84) | 8.8 (2.37 to 20.07) |
Overall survival (OS) was defined as the time from the date of first erlotinib dose to death. OS was compared between patients with FLT-PET response and patients without FLT-PET response, independent of CT response (per RECIST 1.0) at Day 56 of treatment with erlotinib. FLT-PET response was defined as a mSUVmax from FLT-PET scans \<-25%.
| months | Erlotinib_FLT Responders | Erlotinib_ FLT Non-Responders |
|---|---|---|
| Overall Survival of Groups by FLT Response at Day 56 | NA (4.99 to 23.98) | 8.4 (1.94 to 24.51) |
Overall survival (OS) was defined as the time from the date of first erlotinib dose to death. OS was compared between patients with FLT-PET response and patients with FLT-PET progression, within the subset of patients who demonstrated SD on CT (per RECIST 1.0) at Day 56 of treatment with erlotinib. FLT-PET response was defined as a mSUVmax from FLT-PET scans of \<-25% and FLT-PET disease progression was defined as a mSUVmax from FLT-PET scans \>+25% or the development of a new lesion with a mSUVmax above background not explained by another cause.
| months | Erlotinib_FLT Responders With CT SD at Day 56 | Erlotinib_FLT Progressive Disease With CT SD at Day 56 |
|---|---|---|
| Overall Survival of Patients With FLT CR/PR Versus FLT PD in Patients With CT SD at Day 56 | NA (4.99 to 17.84) | 8 (2.37 to 14.29) |
The number of participants who experienced an adverse event judged by the investigator to be related to FLT-PET.
| Participants | Overall Study Participants |
|---|---|
| Number of Participants With Adverse Events Due to FLT-PET Imaging | 0 |
Collected over Screening to Day 112 assessment visit or study discontinuation or termination, whichever is earlier. On visits after Day 112, only Serious Adverse Events were recorded. (Up to 1 year). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Erlotinib | — | 37/85 (43.5%) | 46/85 (54.1%) |
| Event | Erlotinib |
|---|---|
| DISEASE PROGRESSIONGeneral disorders | 5/85 |
| PNEUMONIAInfections and infestations | 4/85 |
| NON-SMALL CELL LUNG CANCERNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 4/85 |
| CONFUSIONAL STATEPsychiatric disorders | 3/85 |
| GASTROINTESTINAL HAEMORRHAGEGastrointestinal disorders | 2/85 |
| FATIGUEGeneral disorders | 2/85 |
| PYREXIAGeneral disorders | 2/85 |
| DEHYDRATIONMetabolism and nutrition disorders | 2/85 |
| BACK PAINMusculoskeletal and connective tissue disorders | 2/85 |
| PNEUMONIA ASPIRATIONRespiratory, thoracic and mediastinal disorders | 2/85 |
| Event | Erlotinib |
|---|---|
| FATIGUEGeneral disorders | 6/85 |
| DISEASE PROGRESSIONGeneral disorders | 5/85 |
| RASHSkin and subcutaneous tissue disorders | 5/85 |
| PNEUMONIAInfections and infestations | 4/85 |
| NON-SMALL CELL LUNG CANCERNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 4/85 |
| BACK PAINMusculoskeletal and connective tissue disorders | 3/85 |
| DYSPNOEARespiratory, thoracic and mediastinal disorders | 3/85 |
| ANAEMIABlood and lymphatic system disorders | 2/85 |
| DIARRHOEAGastrointestinal disorders | 2/85 |
| NAUSEAGastrointestinal disorders | 2/85 |
| Age, Continuous(years) | Erlotinib |
|---|---|
| Mean | 62.9 ± 9.2 |
| Sex: Female, Male(Participants) | Erlotinib |
|---|---|
| Female | 31 |
| Male | 43 |
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Genentech, Inc.